The Mahatma Gandhi Medical College and Research Institute (MGMCRI), a constituent college of Sri Balaji Vidyapeeth, has been chosen as one of the participating centres in the Phase III human clinical trials of Bharat Biotech’s Covaxin for protection against COVID-19.
A press note from the MGMCRI said the phase III clinical trial at the institute had recently been approved by the Directorate of Health and Family Welfare, Government of Puducherry and participation would be based on the norms and stipulated guidelines established by the Central Drugs Control Organisation and Ministry of Health and Family Welfare, Government of India.
Subhash Chandra Parija, Vice Chancellor of Sri Balaji Vidyapeeth, said the MGMCRI was among 21 partnering institutions approved by the Central Licensing Authority in the human trials for Covaxin, an inactivated vaccine, jointly developed by Indian Council for Medical Research (ICMR) and Bharat Biotech Limited, Hyderabad.
Safety and efficacy
The phase III trials for testing the safety and efficacy of corona virus vaccine (BBV152B) is being conducted on an estimated 28,000 subjects.
S.R. Rao, vice-president (Research, Innovation and Development), SBV, said the multi-centre trials would ascertain the efficacy and safety of the inactivated SARS – COV – II Vaccine in adults.
At the MGMCRI, the trials would begin soon and intend to cover 1,200 volunteers. Interested persons can register as volunteers and preference would be accorded to health careworkers, doctors, nurses and security personnel. The details are available at https://sbvu.ac.in/mgmcri/
Nirmal Coumare, Medical Superintendent, MGMCRI, said that the preparation for carrying out the phase III trials are fully in compliance with the guidelines of ICMR, Government of India and Government of Puducherry.
